Comparative Motility of Alloplastic Orbital Implants

Not Applicable

• Conditions: Anophthalmos; Acquired; Evisceration; Traumatic, Eye
• Interventions: Procedure: Evisceration with orbital implantation

• Registration Number: NCT04464109
• Lead Sponsor: Fayoum University Hospital

Brief Summary

This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .

Detailed Description

Evisceration allows removal of the intraocular contents while preserving the sclera and normal extraocular muscle attachments. It is more advantageous than enucleation in patients in whom intraocular tumor is rules out.

Maximizing orbital volume and restoration of movement are important aspects of a successful surgical outcome.

Standard evisceration techniques do not allow placement of an implant larger than 13-16 mm which don't adequately replace the volume leading to postevisceration socket syndrome. Therefore, various techniques have been described to expand the scleral cavity and allow placement of a large implant including anterior sclerotomies, posterior sclerotomies, and disinsertion of optic nerve.

Implant exposure is a terrible complication of evisceration with reported rates as high as 67%. Exposure of the implant can lead to infection, which usually mandates removal of the implant. Trying to minimize this risk, physicians intentionally place the implants posterior to the normal position of the globe. Some authors described placement of the implant posterior to posterior sclera which totally eliminated the risk of exposure.

However, this deep seating of the implant may have deleterious effects on its motility. It can decrease implant-prosthesis interaction. In addition, retro-scleral placement of the implant moves it posterior to the pulleys that serve as the functional origins of rectus muscles. This relationship would be expected to alter the pulling directions of the rectus muscles after evisceration hindering effective implant motility.

In this trial the investigators will try to study the effect of posterior placement of the implants on its motility after evisceration.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-05
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-01
• Last Update Posted: 2020-08-04
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who are candidates for evisceration

Exclusion Criteria

• Inability to provide independent, informed consent
• Significant preoperative motility abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrascleral placement of the implant	Evisceration with orbital implantation	Anterior and posterior sclerotomies with the implant partly in the scleral shell and partly in the intraconal space. 1. Anterior relaxing sclerotomies not reaching the optic nerve 2. A 360° scleral incision around the optic nerve. 3. The anterior sclera flaps are overlapped and closed 4. Part of the implant remains in the scleral shell, while the remaining part is sitting in the intraconal space.
Retro-scleral placement of the implant	Evisceration with orbital implantation	Surgical steps; 1. Two anterior scleral relaxing incisions 2. A 360° scleral incision around the optic nerve to disinsert it 3. Two posterior scleral relaxing incisions 4. The implant is inserted posterior to posterior scleral edges 5. The posterior sclera is closed then the anterior sclera is overlapped and closed. 6. The implant is completely seated in the intraconal space

Primary Outcome Measures

Name	Time	Method
Prosthesis motility	6 months	It will be measured with the kestenbaum's limbus test. Photographs will be taken while patients wearing Kestenbaum spectacles in vertical and horizontal directions of gaze.
Implant motility	6 months	The conjunctiva is marked at the center point of the implant while the patient looking in primary gaze. The excursion of the mark will be measured will a standard millimeter ruler in extreme gaze positions

Secondary Outcome Measures

Name	Time	Method
Volume augmentation	6 months	Exophthalmometry will be performed for all patients after fitting a prosthesis. Enophthalmos is to be graded from 1 to 4 (grade 1 = no postoperative improvement; grade 2 = improvement \<2 mm but remained enophthalmos; grade 3 = improvement ≥2 mm but remained enophthalmos; and grade 4 = no enophthalmos) compared with unaffected side.

Trial Locations

Locations (1)

Mostafa Mohammed Mohammed Diab; 🇪🇬 Fayoum, Egypt